BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM

    K Number: K060333 · Decision Sep 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    211

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    Basic Information

    Device Name
    DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
    K Number
    K060333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dialysis Services, Inc.
    Date Received
    February 9, 2006
    Decision Date
    September 8, 2006
    Product Code
    FIN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FIN Tank, Holding, Dialysis

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    Other Clearances by Dialysis Services, Inc.

    K Number Device Name
    K043344 DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM